36C24224Q0728_1.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

POINT OF CONTACT*

Morgan Weeks Morgan.Weeks1@va.gov Morgan.Weeks1@va.gov

(607) 664-4708

PLACE OF PERFORMANCE

800 Irving Ave

Syracuse NY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Department of Veterans Affairs, Syracuse VA Medical Center located at 800 Irving Avenue Syracuse, NY 13210-2716 has a requirement for Radiopharmaceuticals. The period of performance will be starting on September 4, 2024. This is a Combined Synopsis Solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.5, as supplemented with additional information included in this solicitation. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued. Interested Contractors that respond to this Combined Synopsis Solicitation must provide evidence that they are able to meet all the requirements identified herein. This requirement is being solicitated as unrestricted. The proposed contract action is for supplies for which the Government intends to solicit competitive offers to award a firm fixed price contract. Interested Contractors may submit offers, and all eligible offers received prior to the date listed in SAM.gov shall be considered by the Government. The NAICS code for this requirement is 325412 and the size standard is 1,300 Employees.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05. Only emailed proposals received directly from the offeror shall be considered.

Statement of Work Radiopharmaceuticals

1.0 SCOPE

Statement of Work Radiopharmaceuticals: The Department of Veterans Affairs Central New York Healthcare System at Syracuse, located at 800 Irving Avenue Syracuse, NY 13210-2716 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The Syracuse VA Medical Center (VAMC) intends to award a base year plus two option years, firm fixed price, indefinite delivery, indefinite quantity requirements contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a period of performance of September 04, 2024 through September 03, 2027. The Contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Federal, State and Local Regulations. Further, the Contractor will use non-HEU derived isotopes whenever possible to support the Department of Veterans Affairs procurement initiative. The Contractor shall be able to provide all the items listed in the Schedule of Radiopharmaceuticals with deliveries when required.

1.1 BACKGROUND

The Syracuse VA Medical Center (VAMC) is responsible for providing high quality and timely commodities and services for our Veterans. One area to serve our Veterans is to ensure that the best possible medical supplies are both timely and in accordance with proper regulations with Contractors that are licensed and monitored according to Federal, State and Local Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (US NRC) is responsible for regulating uses of radioactive material, including radiopharmaceuticals. The US NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. The US NRC has transferred regulatory authority over the use of this material to 35 NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA’s Center for Drug Evaluation and Research regulates the radiopharmaceuticals, ensuring effectiveness and patient safety. The mission of The National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.

1.2 STATEMENT OF WORK

1. Contractor agrees to provide all listed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Syracuse VA Medical Center on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors that can deliver in less than two hours to the Syracuse VA Medical Center need to respond to this Request for Proposal. Contractor shall be licensed by the State of New York. Additionally, contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides NY and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with the Request for Proposal. Contractor shall provide evidence of delivery in less than 2 hours with this Request for Proposal. Please identify the location of the point of shipment to the address listed on this Request for Proposal. Verification will be completed via www.mapquest.com

2. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided.

3. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.

4. The Contractor shall label all products delivered as to the Syracuse VA Medical Center with the radiopharmaceutical, activity, time of preparation, expiration time and date.

5. The Contractor shall hold a current unrevoked NRC and/or an agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. Supplier shall provide a copy of their radioactive material license with this proposal. Supplier shall immediately notify the CO and COR, upon any action by the NRC or an agreement state and/or FDA to suspend or modify the radioactive materials license. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and applicable FDA requirements. In addition, all Tc99m generation must come from LEU (Low Enriched Uranium) - Mo-99 sources mandated by VACO NHPP. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

6. The Contractor will provide with their proposal all the following information for paragraphs a through d:

a. Contractor’s regular work hours

b. Contractor’s telephone number for call-in orders during regular work hours.

c. Contractor’s telephone number and instructions for placing “Emergency” orders after contractor’s regular work hours, including weekends.

d. Contractor’s telephone number for expert advice concerning awarded products.

e. Contractor will furnish a statement that any radiopharmaceuticals delivered as “ready-to-use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of the Joint Commission (JC) and/or with the United States Pharmacopeia.

f. Should any changes occur in above information during contract performance period, contractor will immediately provide updates in writing.

7. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the COR at the Syracuse VA Medical Center Imaging Service.

8. The Contractor shall make quality control records available to the COR upon written request from the CO or COR.

9. The Contractor shall test all products for Quality Control periodically this testing shall be performed at no cost to the VA. The contractor shall provide a detailed description of the test upon request.

10. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

11. If an ordered dosage of radioactive material is given to Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

12. Technetium product radiopharmaceuticals not used will be returned for credit the next workday (Including the bulk doses), using the DOT regulations. Credit will be reflected in the current month’s invoice.

13. Contractor shall replace any items delivered damaged or in error at no cost to the VA. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time (as per patient needs).

14. The expiration date and time shall be indicated and affixed to each product as noted below; in general:

a. Ready-to-use doses: not shorter than six (6) hours.

1. b. Tc-99m pertechnetate: Not shorter than twelve (12) hours.

1. c. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery.

1. d. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span.

1.

15. In the event that a quality control or material defect is suspected and/or detected by the COR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

a. Provide technical expertise in calibration.

1. b. Provide professional examination of product; submit results and recommendations to the COR.

1. c. Make expedient replacement of any product suspected of being deficient.

16. PROCEDURE for labeling of patient's white blood cells (WBC) with Indium-111 Oxine or Tc-Ceretec for re-injecting to the same patient:

a. Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:30 PM for the next workday procedure.

1. b. Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Contractor will be at 7:30 AM or later, if so, specified by the COR.

1. c. The return by the Contractor, of the patient's Indium labeled white blood cells will take place not later than within 5 (five) hours from the time of specimen pick up time.

1. d. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure.

17. The Contractor shall pick up Radiopharmaceuticals (used, unused) for proper disposal at no cost to the Government.

18. The Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule.

1.3 Deliverables and Acceptance Criteria

1. The Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below:

a. Provide up to two deliveries per day during regular operating hours to the Syracuse VAMC at no additional charge. The Delivery Charge for STAT orders is to be included on the Schedule of Radiopharmaceuticals. STAT deliveries will average three (3) times a week.

b. Regular daily radiopharmaceutical doses ordered the previous day will be delivered in one morning delivery by 6:30 AM and not split into two separate deliveries with one delivered later in the day.

c. Deliver directly to the Nuclear Medicine department at the Syracuse VAMC daily quantity of radiopharmaceuticals by 6:30 AM as requested from the previous day.

d. Orders can be placed orally by telephone or fax transmission by Ordering Officers provided by the COR.

e. Deliver directly to the Nuclear Medicine Department at the Syracuse VAMC, the quantity of radiopharmaceuticals requested on an emergency basis to arrive in less than two (2) hours after notification.

f. Radioactive dose boxes that are delivered outside of working hours must be placed in the Hot Lab with VA police escort. The Contractor must notify the VA police at the Syracuse VA Medical Center at 315 425-4336. The Contractor making the delivery shall not leave a radioactive materials package at the Syracuse VA Medical Center unless they have verbally communicated with a nuclear medicine staff member or VA Police for the early morning delivery.

g. Other delivery times may be outlined by the Syracuse VAMC in this Statement of Work

2. On Federal Holidays, no normal deliveries will be expected. If Monday is a Federal Holiday no delivery will be expected.

3. Emergency Deliveries may be requested at any time outside normal delivery times, including weekends, holidays, and nights.

4. Shipments requested as an Emergency shall be delivered as follows:

a. Requests placed after regular work hours (weekends, holidays, and nights) will be delivered within two (2) hours, or as specified.

b. Emergency, weekend, and holiday deliveries are to be delivered to the location specified by the Syracuse VAMC, unless otherwise specified when called for.

c. All deliveries will be labeled as “RADIOACTIVE MATERIAL” in compliance with all applicable regulations.

d. All Radiopharmaceuticals, Radioassay Kits, and Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the respective awarded contract and all applicable Federal, State, and Local Laws.

e. Delivery dates, times, frequency of deliveries, specific dosages, and all other specific requirements by the Syracuse VAMC in this Statement of Work will be strictly adhered to.

5. All shipments must have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the Syracuse VAMC Purchase Order Number issued for the current fiscal year, and the Contractor’s invoice number. Providing incorrect Purchase Order numbers on invoices will cause a substantial delay in payments to the Contractor.

1.4 VA OPERATING HOURS

The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. The Contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below except for normal next day delivery.

The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:00 AM. to 4:30 PM Eastern Standard Time Delivery shall be accomplished at 6:30 AM and on an as needed basis during normal operating hours. The Contractor to include up to two (2) deliveries per normal working day during normal working hours as needed at no additional charge.

National Holidays: The ten (10) holidays observed by the Federal Government are as follows: New Year's Day, Martin Luther King's Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, Christmas, and any other day specifically declared by the President of the United States to be a national holiday.

1.5 CONTRACT AWARD

Contractor shall provide the following within 5 business days of award:

1. A copy of their Laboratory’s current quality control manual to the COR.

2. A dedicated inside sales representative to aide in facilitation in the smooth coordination between the Syracuse VAMC and the Contractor’s Laboratory Pharmacy.

3. Material safety data sheets and updates on all delivered products as per contract award to include any additions throughout the period of performance of the awarded contract.

4. Patient orientation education video presentations and other appropriate material at no cost to the Government.

5. The Contractor shall provide signs and posters alerting patients, employees, and the public, of safety precautions in the handling of radioactive materials

1.6 QUALITY REQUIREMENTS

The Contractor shall guarantee the quality of their radiopharmaceuticals. Quality Control (QC) shall include pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the Radiation Safety Officer and COR.

1.7 PERSONNEL POLICY

1. The Contractor is responsible for all costs, including personnel costs, associated with the respective awarded contract, unless otherwise specified.

2. Qualifications - Personnel assigned by the Contractor to prepare and provide the products covered within this Statement of Work shall be Nuclear Pharmacists, or a Licensed Technologist working under the supervision of a Nuclear Pharmacist licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

1.8 SPECIAL CONTRACT REQUIREMENTS: HHS/OIG

To ensure that the individuals providing services under the respective awarded contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding Federal Health Care Programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under the respective awarded contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud or abuse of the Medicare and Medicaid programs. During the period of performance of the respective awarded contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any Healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty imposed against them. By signing their proposal, the Contractor certifies that all persons or entities listed in their proposal have been compared against the OIG list and are NOT listed as of the date their proposal was signed.

1.9 CONTRACTOR STAFF ROLES AND RESPONSIBILITIES

The Contractor must be in compliance with all Nuclear Regulatory Commission, United States Pharmacopeia, United States Food and Drug Administration, State, Local and Joint Commission guidelines, as well as United States Pharmacopeia 797 guidelines.

1.10 CONTRACTOR PERFORMANCE ASSESSMENTS

Assessments: The Government will complete assessments of the Contractor’s performance. The Contractor shall have an opportunity to respond to said assessments.

Record: The Government will keep completed assessments that will serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future contracts.

1.11 DESIGNATION OF CONTRACT OFFICER REPRESENTATION

The COR will be designated in writing. The COR will be furnishing technical guidance and advice regarding the work being performed under the respective awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

1.12 CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITY

The Contractor shall take immediate action to notify the COR whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous, or unsafe to remove such products, equipment, or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment, or items can be made in as expedient and efficient manner as possible. The Contractor shall provide to the COR their plan for this safety notification process and maintain a record system to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR.

1.13 HIPAA COMPLIANCE

The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs.

1.14 PROHIBITION (WORKING OUTSIDE OF US)

The entire performance of the respective awarded contract shall be within the borders of the United States of America. The Contractor shall not access any VA data/information (for example, by remote computer access) from locations that are outside the above-stated borders. Furthermore, the Contractor shall not send, transfer, mail, or otherwise transmit any VA data/information to locations outside the above-stated borders.

1.15 CONTRACT TERM

This IDIQ shall be for a base year with two (2) option years. The base year will run from 09/04/2024 through 09/03/2025.

18.0 Schedule of Required Radiopharmaceuticals

Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses, etc. This excludes emergency deliveries, Pharmacist After-Hour Emergency Call-Back, and Weekend White Blood Cell labeling charge. All four blocks must be completed for each contract year and Not Applicable (N/A) is not an acceptable response for any of these four blocks. Base year contract will be applicable for 09/04/2024 until 09/03/2025. Option year one (1) will be applicable for 09/04/2025 until 09/03/2026. Option year two (2) will be applicable for 09/04/2026 until 09/03/2027.

Base Year (September 04, 2024 – September 03, 2025)

Option Year One (September 04, 2025 – September 03, 2026)

Option Year Two (September 04, 2026 – September 03, 2027)

Total Dollar Amount for long-term contract: ________________________ Weekend White Blood Cell labeling charge31Emergency Delivery: Charge for delivering unscheduled Emergency orders during normal business hours within two (2) hours of receiving the order by phone from the Syracuse VAMC. 2Pharmacist (Emergency after hours): The charge for having a pharmacist called back to the Pharmacy after hours, prepare the ordered dose and have it delivered to the Syracuse VAMC within two (2) hours. (Emergency orders only). 3Weekend WBC labeling charge: The charge for the pharmacy to attach a radionuclide to the patient’s white blood cells on a weekend.

This announcement constitutes the only solicitation. Quotes are being requested and the Government shall award a contract for Radiopharmaceuticals. This combined synopsis solicitation shall result in the award of a firm fixed price contract. The provisions and clauses incorporated into this solicitation document are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) may be accessed on the Internet at https://www.acquisition.gov/content/regulations. The North American Industry Classification System (NAICS) code is 325412 with a size standard of 1,300 employees applies to this solicitation.

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from September 4 through September 3.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 1 dose, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor-

(1) Any order for a single item in excess of 250 Doses;

(2) Any order for a combination of items in excess of 300 Doses or

(3) A series of orders from the same ordering office within 1 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is a definite-quantity, indefinite-delivery contract for the supplies or services specified, and effective for the period stated, in the Schedule.

(b) The Government shall order the quantity of supplies or services specified in the Schedule, and the Contractor shall furnish them when ordered. Delivery or performance shall be at locations designated in orders issued in accordance with the Ordering clause and the Schedule.

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that time shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after September 03, 2027.

52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days.

(End of clause) 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 Days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed three (3) years.

(End of clause) 52.232-18 Availability of Funds (Apr 1984) Funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

(End of clause) VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

VA Notice of Limitations on Subcontracting - Certificate of Compliance for Services and Construction (NOV 2022)

(a) Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that -

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Contracting Officer check the appropriate box below based on the predominant NAICS code assigned to the instant acquisition as set forth in FAR 19.102.]

(i) □ Services. In the case of a contract for services (except construction), the contractor will not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-73 or VOSBs as set forth in 852.219-74. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Other direct costs may be excluded to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service as set forth in 13 CFR 125.6.

(ii) □ General construction. In the case of a contract for general construction, the contractor will not pay more than 85% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-73or VOSBs as set forth in 852.219-74. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 85% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(iii) □ Special trade construction contractors. In the case of a contract for special trade contractors, the contractor will not pay more than 75% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-73 or VOSBs as set forth in 852.219-74. Any work that a similarly situated subcontractor further subcontracts will count towards the 75% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(2) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(3) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating section 1001 of title 18.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance with the limitations on subcontracting requirement. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror's bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee:

Printed Title of Signee:

Signature:

Date:

Company Name and Address:

(End of clause)

VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to: Syracuse VA Medical Center, 800 Irving Ave, Syracuse NY 13210 (End of Clause)

VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

VAAR 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer. Copies of these provisions or clauses are available on the Internet at the Web sites provided in the provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference, or the clause at FAR 52.252-2, Clauses Incorporated by Reference. Copies may also be obtained from the contracting officer.

[Contracting officer shall list all FAR and 48 CFR Chapter 8 (VAAR) provisions and clauses incorporated by reference that must be completed by the offeror or prospective contractor and submitted with the quotation or offer.] (End of provision) VAAR 852.233-70 Protest Content/Alternative Dispute Resolution (SEP 2018)

(a) Any protest filed by an interested party shall -

(1) Include the name, address, fax number, email and telephone number of the protester;

(2) Identify the solicitation and/or contract number;

(3) Include an original signed by the protester or the protester's representative and at least one copy;

(4) Set forth a detailed statement of the legal and factual grounds of the protest, including a description of resulting prejudice to the protester, and provide copies of relevant documents;

(5) Specifically request a ruling of the individual upon whom the protest is served;

(6) State the form of relief requested; and

(7) Provide all information establishing the timeliness of the protest.

(b) Failure to comply with the above may result in dismissal of the protest without further consideration.

(c) Bidders/offerors and Contracting Officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, the Department of Veterans Affairs will not furnish any documentation in an ADR proceeding beyond what is allowed by the Federal Acquisition Regulation.

(End of provision) VAAR 852.233-71 Alternate Protest Procedure (SEP 2018)

(a) As an alternative to filing a protest with the Contracting Officer, an interested party may file a protest by mail or electronically with: Executive Director, Office of Acquisition and Logistics, Risk Management and Compliance Service (003A2C), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420 or Email: EDProtests@va.gov.

(b) The protest will not be considered if the interested party has a protest on the same or similar issue(s) pending with the Contracting Officer.

(End of provision)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (May 2024)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

X (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

__ (11)

(i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

__ (ii) Alternate I (Dec 2023) of 52.204-30.

X (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) ( 31 U.S.C. 6101 note).

X (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (14) [Reserved].

__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) ( 15 U.S.C. 657a).

__ (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (17) [Reserved] __ (18)

(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (19)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

X (20) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 15 U.S.C. 637(d)(2) and (3)).

__ (21)

(i) 52.219-9, Small Business Subcontracting Plan (Sep 2023) ( 15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2023) of 52.219-9.

__ (22)

(i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) ( 15 U.S.C. 637s).

__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) ( 15 U.S.C. 657f).

_X_ (26) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Feb 2024) ( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) ( 15 U.S.C. 637(m)).

__ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) ( 15 U.S.C. 637(m)).

_…